What We Do

Care Access is bringing the future of medicine into the present. Our groundbreaking approach removes the traditional barriers that restrict clinical trial participation to just 3% of physicians and patients. By eliminating this limitation, we help speed up the approval and delivery of essential, life‑saving treatments.

Who We Are

We care deeply. Our people drive our mission to transform access to clinical trials for patients everywhere. We support one another, pursue new ways to advance medicine, and strive to create lasting impact for generations to come.

Position Overview

The Region Manager holds full responsibility for overseeing assigned sites. This includes managing staff, ensuring profitability, and successfully executing all studies while creating a strong point of connection for employees, participants, CROs, and sponsors. The Region Manager leads site operations in alignment with CARE SOPs, GCP, and FDA/ICH guidelines.

What You’ll Do – Key Responsibilities

Personnel:
– Travel to regional sites and meet team members, including PIs, in person at least quarterly
– Hold regular site and regional team meetings
– Meet with PIs at least bi‑weekly
– Ensure training is current
– Conduct weekly one‑on‑one meetings with direct reports
– Review performance and KPIs
– Support ongoing staff development and mentoring
– Maintain documentation for all direct reports
– Provide timely feedback on improvement areas and assist in creating measurable improvement plans
– Escalate issues appropriately and involve HR or the Director of Site Operations when needed
– Implement disciplinary actions when required
– Address underperformance proactively
– Collaborate with HR on Performance Improvement Plans when necessary
– Complete annual performance reviews and ongoing goal‑setting discussions
– Ensure HR policies are followed at all sites
– Confirm all staff are current on annual training and documentation
– Foster a positive, team‑focused environment
– Support high morale and low turnover
– Review and submit time sheets on time for non‑exempt staff
– Review travel and expense requests for policy compliance
– Work with Director of Site Operations on injury reports when needed

New Staff:
– Review candidates, conduct interviews, and provide timely feedback
– Onboard new employees at all regional sites
– Complete new hire checklists
– Meet with new employees daily during their first week to review expectations and training progress
– Meet new hires onsite during their first week
– Ensure all Care Access training is completed before study‑specific training
– Provide additional training resources when applicable

Study Management and Site Workload:
– Work with investigators to evaluate feasibility of new protocols
– Review protocols to identify staffing, procedural, service, and cost needs
– Perform Clinical Research Coordinator duties when needed
– Coordinate Investigator and Sub‑Investigator coverage
– Attend SEVs and SIVs in person or remotely
– Monitor and adjust staff workload to ensure study success
– Collaborate with Study Start‑Up to support timely activation of new trials
– Ensure required study training is completed
– Keep the Director of Site Operations updated on all studies
– Serve as a protocol resource
– Partner with recruitment and marketing teams to optimize enrollment
– Review site metrics regularly to ensure accuracy and progress
– Ensure timely source review for new studies

Quality:
– Oversee CRC work to ensure QC, data entry, and query resolution are completed on time
– Develop and implement workflow‑improving processes that reduce deviations and no‑shows
– Participate in internal and external audits and help manage outcomes
– Address monitoring report items quickly with site teams
– Ensure timely reporting of quality issues in QMS
– Work with Compliance and Quality Assurance teams, participate in RCA, and complete required actions promptly
– Maintain a calendar of monitoring visits and internal audits
– Meet with CRAs during monitoring visits when possible
– Regularly review monitoring follow‑up letters and ensure action items are completed

Financial:
– Partner with Business Development to support feasibility responses and SEV scheduling
– Update Director of Site Operations on study changes affecting revenue
– Ensure proper handling of participant W‑9s for 1099 filings
– Manage staffing coverage across sites
– Reduce hourly staff when appropriate
– Provide coverage when sites are short‑staffed

Site Maintenance:
– Notify Director of Site Operations of any maintenance needs
– Coordinate building and equipment maintenance
– Ensure sites remain clean and organized
– Serve as a regional safety resource with strong knowledge of state/federal regulations and OSHA requirements
– Ensure all staff follow OSHA guidelines
– Confirm that sites have the equipment needed for safe job performance
– Review monthly site checklists and ensure equipment calibrations are up to date
– Assess space needs and collaborate on identifying new or additional space
– Oversee new site builds and site closures

Community Engagement:
– Build relationships with local providers and community leaders
– Participate in community events and patient education with an emphasis on regional diversity initiatives

Physical and Travel Requirements
– Must be willing to travel nationwide up to 50%, depending on project needs

Knowledge, Skills, and Abilities:
– Strong knowledge of medical and research terminology
– Client‑service mindset
– Strong understanding of federal regulations and GCP
– Effective communication with diverse professional teams
– Strong organizational and leadership abilities
– Strong verbal and written communication
– Collaborative and supportive team mindset
– Proficient in clinical trial databases, IWRS, EDC, Word, and Excel
– Ability to manage competing priorities
– Strong critical thinking and problem‑solving skills
– Curiosity, innovation, and comfort with thoughtful risk‑taking
– Friendly and positive under pressure
– Self‑motivated with a strong sense of urgency
– Able to work independently in a fast‑paced environment
– Adaptable to shifting responsibilities and workloads

Certifications, Education, and Experience:
– Bachelor’s degree preferred or equivalent education and experience
– At least 1 year of relevant management experience
– At least 3 years of Clinical Research Coordinator experience required
– 2 years as a Care Access CRC preferred

Benefits (US Full‑Time Employees):
– PTO, sick days, holidays
– 100% paid medical, dental, and vision; 75% for dependents
– HSA plan
– Short‑term disability, long‑term disability, life insurance
– Culture focused on growth and equality
– 401k plan

Diversity and Inclusion

We support patients and researchers from many backgrounds and believe our team should reflect the communities we serve. We foster an inclusive environment where people from all backgrounds feel respected and valued. Diversity strengthens our work and fuels our success.

At Care Access, we advance medical breakthroughs every day. We unite standard care with cutting‑edge research to bring life‑changing therapies to those who need them. We proudly collaborate with leading industry partners, top physicians, and dedicated patient communities.

We are an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability, genetic information, veteran status, or any other protected characteristic.

Care Access cannot currently sponsor work visas.

Employment Statement

Care Access complies with all employment laws and regulations, including those governing pay equity and working conditions. We prohibit all forms of forced or involuntary labor, child labor, and human trafficking and expect the same from all partners, suppliers, and third parties. We are committed to protecting human rights everywhere.